# FDA 483 - ATTWILL Medical Solutions LP - November 04, 2016

Source: https://www.keypedia.com/records/483/attwill-medical-solutions-lp/459fe309-1827-4020-93b1-69f78502b6d8

> FDA 483 for ATTWILL Medical Solutions LP on November 04, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ATTWILL Medical Solutions LP
- Inspection Date: 2016-11-04
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Anteco Pharma LLC, a lyophilization contractor in Lodi, WI, was cited for multiple significant deficiencies related to manufacturing controls and sanitation. The inspection revealed failures in cleaning procedures, inadequate equipment qualification and process validation, and insufficient environmental monitoring, all contributing to potential product contamination. These issues indicate a lack of robust quality systems to ensure product safety and integrity.

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Company: https://www.keypedia.com/companies/attwill-medical-solutions-lp/91753cc3-4842-4288-9b14-273aa292d65c

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d